Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.
Regulatory
FDA Grants Priority Review to RP1 Plus Nivolumab for Advanced Melanoma After Anti–PD-1 Therapy
The FDA has accepted and granted priority review to the biologics license application (BLA) seeking the approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for the treatment of adult patients with advanced melanoma who have received prior treatment with a PD-1 inhibitor–containing regimen.
FDA Receives BLA for RP1 and Nivolumab Combo in Advanced Melanoma
The FDA has received a BLA submission seeking the accelerated approval of RP1 plus nivolumab for the potential treatment of adult patients with advanced melanoma who have received prior treatment with a regimen that contains a PD-1 inhibitor.
NICE Recommends Tebentafusp Reimbursement for HLA-A*02:01+ Uveal Melanoma
NICE has recommended the reimbursement for tebentafusp in HLA-A*02:01–positive unresectable or metastatic uveal melanoma.